NCT01095510

CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12

Open-Label, Single-Dose Study to Evaluate the Response and Pharmacokinetics/Pharmacodynamics of Different Doses of CINRYZE® [C1 Inhibitor (Human)] For Treatment of Acute Angioedema Attacks in Children Less Than 12 Years of Age With Hereditary Angioedema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and tolerability following IV administration of CINRYZE in this study population.

Detailed description

Each subject received CINRYZE for treatment of a single acute angioedema attack.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
BIOLOGICAL	CINRYZE

Timeline

• Start date: 2010-06-02
• Primary completion: 2012-04-17
• Completion: 2012-04-17
• First posted: 2010-03-30
• Last updated: 2021-06-03
• Results posted: 2014-07-25

Locations

11 sites across 3 countries: United States, Germany, Hungary